SPERM WASH MEDIUM WITH GENTAMICIN

K023717 · Conception Technologies · MQL · Dec 13, 2002 · Obstetrics/Gynecology

Device Facts

• Record ID: K023717
• Device Name: SPERM WASH MEDIUM WITH GENTAMICIN
• Applicant: Conception Technologies
• Product Code: MQL · Obstetrics/Gynecology
• Decision Date: Dec 13, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6180
• Device Class: Class 2

Intended Use

Sperm Wash Medium is used for in vitro washing for IUI procedures, incubation and manipulation.

Device Story

Sperm Wash Medium and Sperm Wash Medium with Gentamicin are reproductive media used in clinical laboratory settings. The device facilitates the in vitro washing, incubation, and manipulation of sperm samples prior to intrauterine insemination (IUI) procedures. It is intended for professional use by clinicians or laboratory technicians. The medium provides a controlled environment for sperm processing, aiding in the preparation of samples for assisted reproductive technology. The device does not involve automated processing or software-based analysis.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Reproductive medium for sperm processing. Available in two formulations: standard and with Gentamicin. Classified as Class II, product code 85 MQL.

Indications for Use

Indicated for in vitro washing, incubation, and manipulation of sperm for intrauterine insemination (IUI) procedures.

Regulatory Classification

Identification

Reproductive media and supplement are products that are used for assisted reproduction procedures. Media include liquid and powder versions of various substances that come in direct physical contact with human gametes or embryos (including water, acid solutions used to treat gametes or embryos, rinsing solutions, sperm separation media, supplements, or oil used to cover the media) for the purposes of preparation, maintenance, transfer or storage. Supplements are specific reagents added to media to enhance specific properties of the media (e.g., proteins, sera, antibiotics, etc.).

Special Controls

*Classification.* Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing). The device, when it is phosphate-buffered saline used for washing, and short-term handling and manipulation of gametes and embryos; culture oil used as an overlay for culture media containing gametes and embryos; and water for assisted reproduction applications, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.

Submission Summary (Full Text)

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right.

Food and Drug Administration 200 Corporate Boulevard Rockville MD 20850

DEC 13 2002

Conception Technologies, L.P % Grace Holland, Regulatory Consultant Regulatory Specialists, Inc. 3722 Ave. Sausalito IRVINE CA 92606

#### Re: K023717

Trade/Device Name: Sperm Wash Medium & Sperm Wash Medium with Gentamicin Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive media and supplements

#### Regulatory Class: II

Product Code: 85 MQL Dated: November 4, 2002 Received: November 5, 2002

### Dear Ms. Holland:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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:

Indications for Use Statement

023717

1 . . . .

Page

. ·

| 510(k) Number (if known): | _____________________________________________________________________________________________________________________________________________________ |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|

Sperm Wash Medium Device Name:

Indications For Use:

Sperm Wash Medium is used for in vitro washing for IUI procedures, incubation and manipulation.

## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| | <img alt="Signature" src="signature.png"/> |
|---------------|--------------------------------------------|
| | (Division Sign-Off) |
| | Division of Reproductive, Abdominal, |
| | and Radiological Devices |
| 510(k) Number | K023717 |

| Prescription Use<br>(Per 21 CFR 801.109) | <img alt="Checkmark" src="checkmark.png"/> | OR | Over-The-Counter Use<br>(Optional Format 1-2-96) |
|------------------------------------------|--------------------------------------------|----|--------------------------------------------------|
|------------------------------------------|--------------------------------------------|----|--------------------------------------------------|

REGULATORY SPECIALISTS, INC.

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Indications for Use Statement

Page : 1 of

510(k) Number (if known):

Device Name: Sperm Wash Medium with Gentamicin

Indications For Use:

Sperm Wash Medium is used for in vitro washing for IUI procedures, incubation and manipulation.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elanid A. Seggern

---

(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices 0237 510(k) Number

Prescription Use
(Per 21 CFR 801.109) ✓

OR

Over-The-Counter Use (Optional Format 1-2-96)